The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.
Abbott Molecular Inc.’s recall of certain COVID-19 tests that are at risk of false positive results falls into the class I high-risk category, the US Food and Drug Administration said on 14 October.
The FDA had initially announced the recall of Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP diagnostics on...
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
